Completing a Clinical Evaluation Report (CER) is like learning a new skill. Initially it can seem daunting and difficult, but once you learn a sensible way to execute it, it becomes much easier. Fang Consulting is here to support your company on their path to producing a CER. Contact us with your questions regarding your CER needs.
WHAT IS A CER?
A CER is an assessment of the data gathered, either through a literary analysis or through clinical trials, pertaining to the safety of your device in its intended use.
Stages of a CER are as follows:
- Determine the Scope of Work
- Find Clinical Data Using:
- Literary Analysis
- Clinical Experience
- Clinical Investigation
- Evaluate Data to Determine its Relevance, Quality, and Significance
- Analyze the Data to Find its Strengths and Conclusions
- Determine Whether Findings are Significant and Sufficient
- Produce the CER
A CER is required when attempting to market devices, including Class I devices, globally
Options for preparing a CER (according to MEDDEV 2.7.1 Rev. 4)
- Perform a Clinical Study and Summarize the Results
- Perform a Literary Study of Relevant Clinical Literature
- A Combination of Both
Our team will help you review the data that is relevant to your device by working with data gathered from clinical trials or through a literature review to evaluate the safety of your device in its intended use.